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RECRUITING
NCT07462312
NA

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Sponsor: NeuroBrave ltd.

View on ClinicalTrials.gov

Summary

This randomized controlled trial (RCT) will evaluate the effectiveness of a digital biofeedback-based intervention ("Mental Gym®") designed to reduce Posttraumatic Stress Disorder (PTSD) symptoms and improve mental health. The intervention combines daily HRV biofeedback exercises using a wearable device (Garmin watch), a dedicated mobile application, and weekly group guidance sessions. A delayed-intervention control group design will be used. To account for expected attrition and ensure a final sample of 60 participants, approximately 80 subjects will be recruited. Physiological and self-report data will be collected pre- and post-intervention, weekly during the intervention, and at follow-ups (3 months post-intervention). The study population consists of combat veterans diagnosed with PTSD.

Official title: Evaluating the Efficacy of the "Mental Gym®" Biofeedback-Based Intervention for Combat Veterans Diagnosed With PTSD: A Randomized Controlled Trial

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-09-15

Completion Date

2026-09-30

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

Mental Gym® Biofeedback System

The intervention is an 8-week hybrid program designed to reduce symptoms of PTSD and improve mental health. The program includes weekly online sessions (via Zoom) with a specialist psychologist experienced in biofeedback and trauma therapy. These sessions guide participants through the program, provide education on trauma and autonomic system and explain the biofeedback exercises. In addition to the weekly group sessions, participants engage in a dailyself-practice delivered through the NeuroBrave Sense mobile application, utilizing the provided wearable device ( Garmin watch) for real time biofeedback practices. Supplementary mental practice assignments are also delivered to participants via WhatsApp.

Locations (1)

NeuroBrave LTD - Remote Site

Jerusalem, Israel